SOHO 2025 | Defining cure in multiple myeloma and the significance of the CARTITUDE-1 study

Is it time to call cure in multiple myeloma? This is an important topic that I’ll be talking about here at the SOHO meeting. Why is cure so important to be defined in myeloma? First of all, looking from a patient’s perspective, you know, you can now tell the patient that you have a disease for which there is a cure, as opposed to telling them they are afflicted with a disease which is incurable and invariably fatal. So it gives them hope. There’s a big difference for the patient. Second, to the physicians taking care of the patient. You know, now the physicians can approach the patient and tell them that they have treatment that they can offer the patient which will potentially cure them. And if not with the frontline, even should the cancer comes back, there are treatment options out there that will invariably cure them. So they are fully engaged. They would like to know what is the latest development. And they’ll be happy to refer the patient to clinical trials, especially newly diagnosed myeloma, where there are some treatment options that potentially offer a cure. So third, final issue, defining cure and saying that if you’re in complete remission, MRD negative, PET CT negative for five years, defining a five-year mark at which time we can say these patients are cured is very important because this allows them to do clinical trials in newly diagnosed myeloma patients. They also would like to partner with other pharma partners to be part of a clinical trial that will likely give them a cure for the patient. And also they can bring their assets earlier into clinical trials with randomized clinical trial design, even in first relapse or second and subsequent relapse, rather than waiting for patients to fail three and four lines and unmet medical needs. So this is completely different for pharma. And for regulatory agencies like the FDA and EMEA, this is also important because now they will have evidence-based medicine to support that they can actually approve drugs earlier in the time course. At the end of five years, somebody who is in CR, MRD negative, PET CT negative year after year, they could say this is a good endpoint which reflects in the progression-free survival and overall survival. That is why defining cure at this time for myeloma is important. Now, second question is, how did this come about? So, there was a CARTITUDE-1 study result that was reported in ASCO this year, in EHA this year, and finally it came out as a manuscript in JCO. What was CARTITUDE-1 study and why was it so exciting? So CARTITUDE-1 was the Phase IB/II study of cilta-cel in patients in 2018. At that time, they had, you know, so-called unmet medical need. They had failed three or more prior lines of therapy and they had failed prior exposure to IMiDs, prior exposure to proteasome inhibitors and an anti-CD38 monoclonal antibody. So these patients were either participating in the clinical trial or they could have gone to hospice. And the five-year update with a median follow-up of 61 months, the results were presented. And what was surprising was out of the 97 patients who participated in the clinical trial, 32 or one third of the patients were alive and progression-free at five years and longer. This is an unprecedented result. Not only that, 12 of these patients were studied at one center with annual, sequential, bone marrow, blood test and PET CT and they were all found to have no minimal residual disease at all, no measurable disease. And so this is what is the definition of a cure is that five years with no maintenance they have been in complete remission MRD negative checked out year after year for five years. So this has spurred the moment to start talking about cure in multiple myeloma.

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